Study summary

To investigate the efficacy and safety of Go-Less® on nocturia in elderly men, an open clinical study was performed in Japan.

Study design

Subjects: 45 men (> 65 years) suffering from pollakiuria at night.
Study duration: 6 weeks.
Daily dosage: 875 mg EFLA®940 and 167 mg soybean germ extract during weeks 1-2, 525 resp. 100 mg during the following weeks.

Participants were asked to record diurnal and nocturnal urination frequency and subjective degree of satisfaction daily. Efficacy was rated as one of four grades by the investigator. Statistical significance was deter-mined by comparison of the mean before (initial) and after dosing using paired t-test. Laboratory tests and recorded vital signs and adverse events were analyzed for safety and tolerance assessment.

Results

Change In Urination Frequency

For all analysis 3 groups were built; Total, group A (with concurrent use of pollakiuria drugs) and group B. Within Group B and Total the frequency of nocturnal urination already markedly improved at week 2 of treatment, with a further decrease after 6 weeks of treatment (both p<0.01).
Whereas, in group A no differences were seen.

Sleeping Satisfaction

The sleep satisfaction level was scored the following; satisfied 2 points, slightly satisfied 1, slightly unsatisfied -1, unsatisfied -2. A significant improvement was seen in the Group B and the Total (p<0.01).

Total Rate of Improvement

EFLA®940/soybean extract combination also significantly improved the quality of life, as concluded from the participants’ subjective judgment.

The improvement level of patients who suffered from complications from prostatic hypertrophy remained unchanged whereas patients suffering from prostatic hypertrophy in the early stage showed increased levels
of improvement.

Safety

The study product showed high compliance and demonstrated high safety and tolerance